Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Biliary Strictures Clinical Trial

Official title:

Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343160
• Other study ID #: VBR CS 156
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: May 2015

Study information

• Verified date: March 2021
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis

• Subject is =18 years of age

• Subject is able to comply with study protocol and follow-up requirements

• Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form

Exclusion Criteria:

• Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)

• Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent

• The subject has malignant biliary disease

• Subject has known pregnancy

• Participated in protocol involving investigational drug or device within 90 days prior to entry into this study

Related Conditions & MeSH terms

• Biliary Strictures
• Cholestasis
• Constriction, Pathologic

Intervention

Device:
• GORE® VIABIL® Biliary Endoprosthesis
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary Device Patency	Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).	12 Months
Other	Successful Delivery and Deployment	This requires successful delivery and deployment of the device at the intended site.	Upon Implant
Other	Successful Treatment of Benign Stricture Upon Implant	Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution".	Upon implant
Other	Secondary Patency		12 Months
Other	Viability of Treatment	Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal.	Upon Removal
Other	Secondary Patency Post Study Device Removal	Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution.	15 Months
Other	Primary Patency of Treated Stricture	Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.	15 Months
Primary	Safe Stent Removal	The stent removal is considered safe when the Study Device is removed successfully and without SAEs.	Upon Removal